FDA 483 - Scientific Pharmaceuticals, Inc. - April 15, 2026

Scientific Pharmaceuticals, Inc. in Pomona, CA, received a Form FDA 483 with three observations related to its Class II medical device, CuRay Match Flowable Composite Restorative. The inspection revealed significant deficiencies in design and development file maintenance, process validation for manufacturing, and the establishment of adequate risk management processes throughout the product lifecycle. These issues indicate a lack of robust quality system controls for medical device production.